The following data is part of a premarket notification filed by Denali R&d Corporation with the FDA for Cercom Cement.
| Device ID | K083398 |
| 510k Number | K083398 |
| Device Name: | CERCOM CEMENT |
| Classification | Cement, Dental |
| Applicant | DENALI R&D CORPORATION 134 OLD WASHINGTON STREET Hanover, MA 02339 |
| Contact | Jan G Stannard |
| Correspondent | Jan G Stannard DENALI R&D CORPORATION 134 OLD WASHINGTON STREET Hanover, MA 02339 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-17 |
| Decision Date | 2009-01-26 |
| Summary: | summary |